SPY002-072 for Healthy Volunteers

Recruiting at 3 trial locations

Overseen By Medical Director, Clinical Development

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Spyre Therapeutics, Inc.

Disqualifiers: Drug abuse, Alcoholism, Smoking, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPY002-072, aiming to determine its safety and tolerability in healthy individuals. Participants will receive either a single dose of the treatment or a placebo (a harmless pill with no active medication) for comparison. This trial suits healthy men and women who can commit to all study visits and activities. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but since it is for healthy volunteers, it is likely that participants should not be on any regular medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that single doses of SPY002 and SPY072, collectively known as SPY002-072, are well-tolerated at doses up to 1500 mg, meaning most people did not experience serious side effects. Independent research supports these findings, suggesting that these doses are likely safe. In the ongoing Phase 1 study, the primary goal is to assess the safety and tolerability of SPY002-072 in healthy volunteers. Although detailed information about SPY002-072 is limited, safety results from similar compounds are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SPY002-072 is unique because it explores a new way of delivering treatment, specifically through a single dose format with dose escalation. This approach contrasts with many current treatments that might require multiple doses over time. Researchers are excited about SPY002-072 because it could offer a more efficient option, potentially leading to quicker results with fewer doses, which is always a win for patient convenience and compliance.

What evidence suggests that SPY002-072 could be effective?

Research has shown that SPY002-072, which participants in this trial may receive, was well tolerated in earlier studies. It appears promising because it effectively targets TL1A, a factor in inflammation, for up to 20 weeks. This suggests potential benefits for inflammation-related conditions. Early results also indicate it could be effective with treatments every three months or even less frequently, offering convenience for patients. Although the data remains in the early stages, the consistent targeting is a positive sign. ^{1 2 3 4 6}

Who Is on the Research Team?

Joshua Friedman, MD

Principal Investigator

Spyre Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy men and women who can commit to staying at the study site for a set period and return for follow-up visits. Participants must be willing to comply with all testing requirements.

Inclusion Criteria

I am a healthy man or woman.

I can attend all required study visits and follow the study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of SPY002-072 or placebo in a dose escalation format

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SPY002-072

Trial Overview The trial is testing SPY002-072, a new drug, against a placebo (a substance with no active drug). It's designed to check the safety, tolerability, and how the body processes the drug in those who take it.

How Is the Trial Designed?

Group I: SAD Cohorts, Experimental Arm Experimental Treatment 1 Intervention

Participants will receive a single dose of SPY002-072 in a dose escalation format

Group II: SAD Cohorts, Placebo Arm Placebo Group 1 Intervention

Participants will receive a single dose of placebo

Who Is Running the Clinical Trial?

Spyre Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

270+

Novotech (Australia) Pty Limited

Industry Sponsor

Trials

76

Recruited

7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD

Altasciences Company Inc.

Industry Sponsor

Trials

18

Recruited

860+

Published Research Related to This Trial

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

The workshop highlighted the potential of using very low dose human studies (microdoses) to assess drug candidates earlier in the development process, which could improve the selection of effective drugs while ensuring volunteer safety.

Incorporating advanced techniques like accelerator mass spectrometry (AMS) and positron emission tomography (PET) in these early human studies could provide valuable data on how drugs are processed in the body, potentially reducing reliance on animal testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. Combes, RD., Berridge, T., Connelly, J., et al.[2019]

Stealth, an adulterant claimed to be undetectable, was found to effectively mask positive drug tests for substances like THC, LSD, and morphine by causing samples to screen negative in immunoassays.

Despite not altering standard urine parameters that indicate adulteration, Stealth's ability to interfere with drug detection poses a significant challenge for drug testing accuracy, as it can convert authentic positive samples into negative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Stealth adulterant on immunoassay testing for drugs of abuse. Cody, JT., Valtier, S.[2019]

A rapid method using time-of-flight mass spectrometry and direct analysis in real time successfully identified and quantified the synthetic cannabinoid JWH-018 in various 'Spice' products in under five minutes without any sample preparation.

The extraction process yielded clean samples with high recovery rates (97%) and quantified JWH-018 levels in different products, with concentrations ranging from 28 to 90 mg/g of plant material, indicating significant variability in synthetic cannabinoid content across products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification, extraction and quantification of the synthetic cannabinoid JWH-018 from commercially available herbal marijuana alternatives. Dunham, SJ., Hooker, PD., Hyde, RM.[2012]

A new gas chromatography-mass spectrometry (GC-MS) method was developed to effectively detect metabolites of JWH-018, a banned substance found in 'K2' or 'Spice', in urine samples from suspected users.

The study identified specific hydrolysis products of JWH-018 metabolites, including 4-hydroxypentyl and 5-hydroxypentyl, which are comparable to existing detection methods, indicating the reliability of this new analytical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas chromatography-mass spectrometry of JWH-018 metabolites in urine samples with direct comparison to analytical standards. Emerson, B., Durham, B., Gidden, J., et al.[2021]

A case study revealed that anti-motion sickness transdermal patches marketed as natural contained undeclared active substances, including the antihistamine Diphenhydramine, posing potential health risks.

The analysis also found trace elements, some of which could be toxic, highlighting significant safety concerns regarding the unregulated sale of these patches online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances. Gaudiano, MC., Bertocchi, P., De Orsi, D., et al.[2022]

The herbal product Buzz, containing 5.4% JWH-018, produced dose-related behavioral effects in mice that were similar to those of marijuana, indicating significant pharmacological activity.

The effects of Buzz were mediated by CB(1) receptors, and the study highlighted the potential public health risks associated with synthetic cannabinoids due to their increased potency and variable composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalation exposure to smoke from synthetic "marijuana" produces potent cannabimimetic effects in mice. Wiebelhaus, JM., Poklis, JL., Poklis, A., et al.[2021]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

Citations

1. ir.spyre.com ir.spyre.com/news-releases/news-release-details/spyre-therapeutics-announces-positive-interim-phase-1-results

Release Details SPY002 and SPY072 were well tolerated, exhibited PK that supports quarterly or less frequent dosing, and fully engaged TL1A through up to 20 weeks of follow-up.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06672718

A Study of SPY002-091 in Healthy Volunteers This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06622070

NCT06622070 | A Study of SPY002-072 in Healthy ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. prnewswire.com prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-phase-1-results-for-two-next-generation-tl1a-antibody-programs-and-provides-clinical-development-updates-expected-to-deliver-9-phase-2-readouts-302483628.html

Spyre Therapeutics Announces Positive Interim Phase 1 ... SPY002 and SPY072 were well tolerated, exhibited PK that supports quarterly or less frequent dosing, and fully engaged TL1A through up to 20 weeks of follow-up.

5. trialx.com trialx.com/clinical-trials/listings/303035/a-study-of-spy002-091-in-healthy-volunteers/?&radius=10&place=A&user_country=Almada%20N

A Study of SPY002-091 in Healthy Volunteers Overview. This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2024-3a9d0

SPY002-091 Safety Study in Healthy Volunteers SPY002-091 is unique because it is being tested in healthy volunteers at very low doses (microdoses) to assess its safety and metabolism early in the drug ...